Work under the guidance of the Investigator to assist with all study-related responsibilities
Conduct and document the informed consent process
Educate participants on study procedures, duration, risks, benefits, and compensation
Assist in subject enrollment and assign screening codes
Maintain follow-up communication with participants

Study Conduct & Compliance

Ensure strict adherence to
GCP
,
Ethics Committee (EC)
guidelines, and the approved protocol
Follow the
Schedule of Assessments
in coordination with the study team
Coordinate lab activities: sample collection, processing, packaging, and shipping
Ensure subject well-being and protocol compliance

Data Collection & Documentation

Maintain confidentiality while collecting and handling source data
Compile data from medical charts, lab reports, diaries, and questionnaires
Transcribe data from source documents to CRFs (Case Report Forms)
Ensure accuracy and completeness of data in CRFs
Report missing or inconsistent data to the Investigator or Manager
Resolve queries and document all relevant issues or deviations

Safety Monitoring

Record and report
Adverse Events (AE)
and
Serious Adverse Events (SAE)
per guidelines
Communicate safety concerns with P.I., monitor, sponsor, and EC

Regulatory & Site Coordination

Maintain and update the
Site Master File (SMF)
and study documentation
Coordinate with monitors for
Site Initiation Visits (SIV)
and
Routine Monitoring Visits (RMV)
Support audits and inspections by sponsors or regulatory bodies
Manage study closeout activities

Logistics & Operations

Reorder study supplies as needed
Manage and document study subject payments (if applicable)
Record all essential communications and maintain logs

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